Director of AI Medical Devices

Job Summary

A company is looking for a Director, AI Medical Device Programs to lead the development and regulatory execution of AI-powered medical devices.

Key Responsibilities

• Own the lifecycle of AI medical devices from R&D through post-market surveillance
• Lead regulatory strategy for AI/ML products to ensure compliance with global standards
• Drive post-market monitoring programs, including performance tracking and continuous improvement cycles

Required Qualifications

• 5+ years of experience in SaMD and AI/ML product development, with 3+ years in a regulated healthcare setting
• Proven track record leading cross-functional teams through design, development, and regulatory clearance of AI-based medical products
• Deep understanding of medical imaging, computer vision, and model validation in clinical contexts
• Strong command of relevant regulatory frameworks, including FDA 510(k) and ISO 13485
• Experience in a fast-paced, startup or growth-stage healthcare environment is a plus